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Ear-Zap therapy could spare kids from steroid side effects

NCT ID NCT05588063

Disease control Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a non-invasive device that gently stimulates a nerve in the ear to see if it can help control nephrotic syndrome in children aged 3-17. The goal is to reduce relapses and the need for steroids or other immune-suppressing drugs. Thirty children will be randomly assigned to receive either the real stimulation or a sham (fake) treatment to measure safety and effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * FRNS * Age 3-17 years * Glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2 * Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy) * Steroid sensitive nephrotic syndrome (prior history of remission within 4 weeks of steroid therapy) * In remission at time of enrollment (remission defined as UPC \<0.2 or negative dipstick for 3 consecutive days) * Informed consent from the parent or guardian and assent from a minor of ≥ 7. years Exclusion Criteria: * Secondary forms of nephrotic syndrome * SRNS * Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids) * Exposure to steroids within 14 days of enrollment * Receiving any standing immunosuppression (previous exposure \> 2 months allowed and/or B cell repletion) * Any known inflammatory condition (e.g. systemic lupus erythematosis) * History of cardiac disease (arrhythmias, structural/functional abnormalities) * Implantable electronic devices * Pregnancy * Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

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Conditions

The condition(s) this trial relates to.

focal segmental glomerulosclerosis lipoid nephrosis nephrotic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Focal segmental glomerulosclerosis Minimal change disease Nephrotic syndrome in children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19102, United States

  • Cohen Children's Medical Center

    RECRUITING

    New Hyde Park, New York, 11040, United States

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